{
    "info": {
        "nct_id": "NCT06830382",
        "official_title": "A Multicentre, Prospective, Open-label Study With [68Ga]Ga-ABY-025 PET-imaging to Characterize HER2-expression and Explore the Therapy-predictive Value for HER2-antibody Drug Conjugates in Patients With Metastatic Breast Cancer",
        "inclusion_criteria": "* Female patients age ≥18 years.\n* Metastatic or locally advanced breast cancer with disease progression after ≥ 1 line of chemotherapy in the palliative setting, or with disease relapse within six months after completion of (neo-) adjuvant chemotherapy.\n* The patient must be able and willing to provide written consent to participate in the study.\n* At least one metastatic lesion ≥ 10 mm is available for biopsy\n\n  o Exception can be made when a recent biopsy is available (no more than three months old and without exposition to systemic anti-cancer therapy or local radiotherapy to the specific lesion).\n* At least one additional metastatic index lesion ≥ 10 mm for evaluation of treatment effect (according to RECIST v1.1)\n* WHO performance status ≤ 2.\n* Expected survival > 12 weeks.\n* Contraceptives: Females of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of the study treatment phase and for six months after the last dose of [68Ga]Ga-ABY-025. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone- releasing intrauterine devices (IUDs), and copper IUDs. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Women must refrain from donating eggs during this same period. Should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. If a female participant is of child-bearing potential (females are considered not of childbearing potential if they are at least one year postmenopausal and/or surgically sterile), she must have a documented negative serum Pregnancy testing prior to each administration of the IMP is obligatory.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Contra-indications for treatment for trastuzumab deruxtecan and inability to undergo this treatment as per local treatment routines.\n* A previously documented metastatic tumor biopsy that was HER2-positive (IHC 3+ and/or HER2 gene amplification).\n* Other manifest malignancies except for basal cell carcinoma of the skin.\n* Inadequate cardiac, renal, bone marrow or liver function\n* Patients with increased risk of complications from biopsies, i.e. increased risk of bleeding, defined as\n\n  * prothrombin time test (INR value) >1.4, platelet count <70 (109/l), activated partial thromboplastin time (APTT) >30s.\n  * known bleeding disorders such as haemophilia, von Willebrand disease or platelet disorders.\n  * any anticoagulants or antiplatelet treatment that cannot be temporarily paused",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Female patients age ≥18 years.",
            "criterions": [
                {
                    "exact_snippets": "Female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected gender",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "age ≥18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic or locally advanced breast cancer with disease progression after ≥ 1 line of chemotherapy in the palliative setting, or with disease relapse within six months after completion of (neo-) adjuvant chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Metastatic or locally advanced breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "locally advanced"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "disease progression after ≥ 1 line of chemotherapy in the palliative setting",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": "≥ 1 line of chemotherapy in the palliative setting"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease relapse within six months after completion of (neo-) adjuvant chemotherapy",
                    "criterion": "disease relapse",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient must be able and willing to provide written consent to participate in the study.",
            "criterions": [
                {
                    "exact_snippets": "able and willing to provide written consent",
                    "criterion": "consent to participate",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one metastatic lesion ≥ 10 mm is available for biopsy",
            "criterions": [
                {
                    "exact_snippets": "At least one metastatic lesion ≥ 10 mm is available for biopsy",
                    "criterion": "metastatic lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        },
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "o Exception can be made when a recent biopsy is available (no more than three months old and without exposition to systemic anti-cancer therapy or local radiotherapy to the specific lesion).",
            "criterions": [
                {
                    "exact_snippets": "recent biopsy is available",
                    "criterion": "biopsy availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no more than three months old",
                    "criterion": "biopsy age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without exposition to systemic anti-cancer therapy",
                    "criterion": "exposition to systemic anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "exposition",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without ... local radiotherapy to the specific lesion",
                    "criterion": "exposition to local radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "exposition",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one additional metastatic index lesion ≥ 10 mm for evaluation of treatment effect (according to RECIST v1.1)",
            "criterions": [
                {
                    "exact_snippets": "At least one additional metastatic index lesion ≥ 10 mm",
                    "criterion": "metastatic index lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WHO performance status ≤ 2.",
            "criterions": [
                {
                    "exact_snippets": "WHO performance status ≤ 2",
                    "criterion": "WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Expected survival > 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Expected survival > 12 weeks.",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraceptives: Females of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of the study treatment phase and for six months after the last dose of [68Ga]Ga-ABY-025. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone- releasing intrauterine devices (IUDs), and copper IUDs. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Women must refrain from donating eggs during this same period. Should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. If a female participant is of child-bearing potential (females are considered not of childbearing potential if they are at least one year postmenopausal and/or surgically sterile), she must have a documented negative serum Pregnancy testing prior to each administration of the IMP is obligatory.",
            "criterions": [
                {
                    "exact_snippets": "Females of child-bearing potential must agree to use adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for the duration of the study treatment phase and for six months after the last dose",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "for the duration of the study treatment phase and for six months after the last dose"
                        }
                    ]
                },
                {
                    "exact_snippets": "contraceptive methods with a failure rate of < 1% per year",
                    "criterion": "contraceptive method failure rate",
                    "requirements": [
                        {
                            "requirement_type": "failure rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "% per year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone- releasing intrauterine devices (IUDs), and copper IUDs",
                    "criterion": "acceptable contraceptive methods",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "bilateral tubal ligation",
                                "male sterilization",
                                "hormonal contraceptives that inhibit ovulation",
                                "hormone-releasing intrauterine devices (IUDs)",
                                "copper IUDs"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception",
                    "criterion": "unacceptable contraceptive methods",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "Periodic abstinence",
                                "withdrawal"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Women must refrain from donating eggs during this same period",
                    "criterion": "egg donation",
                    "requirements": [
                        {
                            "requirement_type": "refrain",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately",
                    "criterion": "pregnancy reporting",
                    "requirements": [
                        {
                            "requirement_type": "reporting",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "If a female participant is of child-bearing potential (females are considered not of childbearing potential if they are at least one year postmenopausal and/or surgically sterile)",
                    "criterion": "child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "females are considered not of childbearing potential if they are at least one year postmenopausal and/or surgically sterile"
                        }
                    ]
                },
                {
                    "exact_snippets": "she must have a documented negative serum Pregnancy testing prior to each administration of the IMP is obligatory",
                    "criterion": "pregnancy testing",
                    "requirements": [
                        {
                            "requirement_type": "testing",
                            "expected_value": "documented negative serum pregnancy test prior to each administration of the IMP"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Contra-indications for treatment for trastuzumab deruxtecan and inability to undergo this treatment as per local treatment routines.",
            "criterions": [
                {
                    "exact_snippets": "Contra-indications for treatment for trastuzumab deruxtecan",
                    "criterion": "contra-indications for trastuzumab deruxtecan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to undergo this treatment",
                    "criterion": "ability to undergo trastuzumab deruxtecan treatment",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A previously documented metastatic tumor biopsy that was HER2-positive (IHC 3+ and/or HER2 gene amplification).",
            "criterions": [
                {
                    "exact_snippets": "previously documented metastatic tumor biopsy",
                    "criterion": "metastatic tumor biopsy",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2-positive (IHC 3+ and/or HER2 gene amplification)",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "positivity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "IHC score",
                            "expected_value": "3+"
                        },
                        {
                            "requirement_type": "gene amplification",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other manifest malignancies except for basal cell carcinoma of the skin.",
            "criterions": [
                {
                    "exact_snippets": "Other manifest malignancies except for basal cell carcinoma of the skin.",
                    "criterion": "manifest malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "exception",
                            "expected_value": "basal cell carcinoma of the skin"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inadequate cardiac, renal, bone marrow or liver function",
            "criterions": [
                {
                    "exact_snippets": "Inadequate cardiac ... function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequate ... renal ... function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequate ... bone marrow ... function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequate ... liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with increased risk of complications from biopsies, i.e. increased risk of bleeding, defined as",
            "criterions": [
                {
                    "exact_snippets": "increased risk of complications from biopsies",
                    "criterion": "risk of complications from biopsies",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "increased"
                        }
                    ]
                },
                {
                    "exact_snippets": "increased risk of bleeding",
                    "criterion": "risk of bleeding",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "increased"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* prothrombin time test (INR value) >1.4, platelet count <70 (109/l), activated partial thromboplastin time (APTT) >30s.",
            "criterions": [
                {
                    "exact_snippets": "prothrombin time test (INR value) >1.4",
                    "criterion": "prothrombin time test (INR value)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.4,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count <70 (109/l)",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 70,
                                "unit": "109/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "activated partial thromboplastin time (APTT) >30s",
                    "criterion": "activated partial thromboplastin time (APTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "s"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* known bleeding disorders such as haemophilia, von Willebrand disease or platelet disorders.",
            "criterions": [
                {
                    "exact_snippets": "known bleeding disorders such as haemophilia",
                    "criterion": "bleeding disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known bleeding disorders such as ... von Willebrand disease",
                    "criterion": "von Willebrand disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known bleeding disorders such as ... platelet disorders",
                    "criterion": "platelet disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* any anticoagulants or antiplatelet treatment that cannot be temporarily paused",
            "criterions": [
                {
                    "exact_snippets": "any anticoagulants or antiplatelet treatment",
                    "criterion": "anticoagulant or antiplatelet treatment",
                    "requirements": [
                        {
                            "requirement_type": "ability to pause",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}